NCT00083083

Fludeoxyglucose F18 Positron Emission Tomography Imaging In Assessing Patients Before and After Treatment for Locally Advanced Non-Small Cell Lung Cancer

Positron Emission Tomography Pre- and Post-treatment Assessment For Locally Advanced Non-Small Cell Lung Carcinoma

• Status: Unknown
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 250 (estimated)
• Sponsor: American College of Radiology Imaging Network · Network
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

RATIONALE: Imaging procedures, such as fludeoxyglucose F18 positron emission tomography (\^18FDG-PET), may improve the ability to detect disease progression and help doctors predict a patient's response to treatment and plan more effective treatment. PURPOSE: This phase II trial is studying how well \^18FDG-PET imaging works in detecting disease progression and determining response to treatment in patients who are undergoing chemoradiotherapy for locally advanced non-small cell lung cancer.

Detailed description

OBJECTIVES: Primary * Determine whether peak standardized uptake value (SUV) for fludeoxyglucose F 18 positron emission tomography (FDG-PET) shortly after definitive chemoradiotherapy is predictive of long-term survival of patients with inoperable stage IIB or III non-small cell lung cancer. Secondary * Determine whether max SUV for FDG-PET shortly after definitive chemoradiotherapy is predictive of long-term survival in these patients. * Determine whether post-treatment imaging using peak and max SUV for FDG-PET shortly after definitive chemoradiotherapy is predictive of local disease control in these patients. * Determine whether pre-treatment imaging using these techniques is predictive of long-term survival and local disease control in these patients. * Correlate, if possible, Ki-67 expression with overall survival of patients assessed with these imaging techniques. OUTLINE: This is a diagnostic, multicenter study. Before starting chemoradiotherapy, patients undergo baseline whole-body positron emission tomography (PET) imaging. Patients receive fludeoxyglucose F 18 (\^18FDG) IV followed 50-70 minutes later by PET imaging. Patients then receive concurrent definitive radiotherapy and chemotherapy. Patients enrolled in other treatment-oriented clinical trials receive therapy as per that trial. Other patients receive standard thoracic radiotherapy (dose ≥ 60 Gy) and standard chemotherapy comprising a platin (cisplatin or carboplatin) and a second non-platin, non-gemcitabine drug (etoposide, vinblastine, vinorelbine, paclitaxel, or docetaxel). Approximately 14 weeks after completion of chemoradiotherapy and adjuvant chemotherapy (if given), patients undergo post-treatment \^18FDG-PET imaging. Patients are followed every 3 months for 2 years and then every 6 months for at least 1 year. PROJECTED ACCRUAL: A total of 250 patients (including at least 75 with stage IIB/IIIA disease and at least 75 with stage IIIB disease) will be accrued for this study within 2 years.

Conditions

• Lung Cancer

Interventions

Type	Name	Description
DRUG	carboplatin
DRUG	cisplatin
DRUG	docetaxel
DRUG	etoposide
DRUG	paclitaxel
DRUG	vinblastine sulfate
DRUG	vinorelbine tartrate
GENETIC	gene expression analysis
PROCEDURE	positron emission tomography
RADIATION	fludeoxyglucose F 18
RADIATION	radiation therapy

Timeline

• Start date: 2005-03-01
• Primary completion: 2006-06-01
• First posted: 2004-05-17
• Last updated: 2011-03-01

Locations

49 sites across 3 countries: United States, Canada, South Korea